standards > terminology artifact > DOI:10.25504/FAIRsharing.ad3137


ready Medical Dictionary for Regulatory Activities Terminology

Abbreviation: MedDRA


General Information
MedDRA is a multilingual terminology allowing most users to operate in their native languages. MedDRA can be used to analyse individual medical events (e.g., “Influenza”) or issues involving a system, organ or etiology (e.g., infections) using its hierarchical structure. MedDRA can be used for signal detection and monitoring of clinical syndromes whose symptoms encompass numerous systems or organs using its multi-axial hierarchy or through the special feature of Standardised MedDRA Queries. The ability to communicate adverse event data is another strength of MedDRA and has lead to MedDRA being an integral part of the ICH e-submission standards: eCTD (ICH M8) and ICSRs (ICH E2B).


This record replaces or incorporates the following deprecated resources:

Homepage http://www.meddra.org/

Countries that developed this resource United States

Created in 1993

Taxonomic range

Knowledge Domains 




How to cite this record FAIRsharing.org: MedDRA; Medical Dictionary for Regulatory Activities Terminology; DOI: https://doi.org/10.25504/FAIRsharing.ad3137; Last edited: June 27, 2019, 2 p.m.; Last accessed: Sep 19 2019 11:51 p.m.


This record is maintained by MedDRAMSSO

Record updated: June 27, 2019, 2 p.m. by The FAIRsharing Team.

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Tools

Schemas

No XSD schemas defined


Access / Retrieve Data

Conditions of Use

Applies to: Data use

Data Access




Publications

The use of a medical dictionary for regulatory activities terminology (MedDRA) in prescription-event monitoring in Japan (J-PEM).

Yokotsuka M,Aoyama M,Kubota K
Int J Med Inform 2000

View Paper (PubMed)

The medical dictionary for regulatory activities (MedDRA).

Brown EG,Wood L,Wood S
Drug Saf 1999

View Paper (PubMed) View Publication

MEDDRA Ontology Display

View in BioPortal.


Disclaimer: This widget assumes the availability of the ontology resources in the NCBO BioPortal.


Related Standards

Reporting Guidelines

No guidelines defined

Terminology Artifacts

No semantic standards defined

Identifier Schemas

No identifier schema standards defined

Metrics

No metrics standards defined


Implementing Databases (5)
Orphanet
Orphanet is the reference resource for information on rare diseases and orphan drugs for all publics. Its aim is to contribute to the improvement of the diagnosis, care and treatment of patients with rare diseases. Orphanet maintains the Orphanet nomenclature, essential for interoperability, and the Orphanet Rare Disease Ontology (ORDO).

European Union Drug Regulating Authorities Clinical Trials
EudraCT (European Union Drug Regulating Authorities Clinical Trials) is the European Clinical Trials Database of all interventional clinical trials of medicinal products commencing in the European Union from 1 May 2004 onwards. The EudraCT database has been established in accordance with Directive 2001/20/EC.

Disbiome
Disbiome is a database covering microbial composition changes in different kinds of diseases. Disease names, detection methods or organism names can be used as search queries giving that return information related to the experiment (related disease/bacteria, abundancy subject/control, control type, detection method and related literature).

VigiBase
VigiBase is the WHO global database of individual case safety reports (ICSRs). It is the largest database of its kind in the world, with over 20 million reports of suspected adverse effects of medicines, submitted, since 1968, by member countries of the WHO Programme for International Drug Monitoring. It is continuously updated with incoming reports. It is linked to a number of medical and drug classifications such as WHO-ART, MedDRA, WHO ICD, and WHODrug.

Canada Vigilance Adverse Reaction Online Database
The Canada Vigilance Adverse Reaction Online Database contains information about suspected adverse reactions (also known as side effects) to health products. Adverse reaction reports are submitted by: consumers and health professionals, who submit reports voluntarily; and manufacturers and distributors (also known as market authorization holders), who are required to submit reports according to the Food and Drugs Act. Data is stored from 1965 onwards.

Implementing Policies

This record is not implemented by any policy.